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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10 FULL AUGMENT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

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ARTHREX, INC. 24MM BASEPLATE, 10 FULL AUGMENT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 24MM BASEPLATE, 10° FULL AUGMENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 02/24/2021
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported through the surgical outcome system that a pulmonary embolism resulting in inpatient hospitalization occurred during a shoulder arthroplasty procedure in which arthrex product was being used.The patient was treated with concomitant medication.The facility reported that the patient has been discharged from the hospital and is recovering.
 
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Brand Name
24MM BASEPLATE, 10 FULL AUGMENT
Type of Device
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key11484215
MDR Text Key239787183
Report Number1220246-2021-02733
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888867341630
UDI-Public00888867341630
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number24MM BASEPLATE, 10° FULL AUGMENT
Device Catalogue NumberAR-9580-2410
Device Lot Number04521947
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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